Butorphanol Nasal Spray

IMPORTANT WARNING:

Butorphanol nasal spray may be habit forming, especially with prolonged use. Use butorphanol nasal spray exactly as directed. Do not use more of it, use it more often, or use it in a different way than directed by your doctor. While using butorphanol nasal spray, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse butorphanol if you have or have ever had any of these conditions. Talk to your health care provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Butorphanol nasal spray may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to use butorphanol nasal spray. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a head injury, brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Do not allow anyone else to use your medication. Butorphanol nasal spray may harm or cause death to other people who use your medication, especially children. Keep butorphanol nasal spray in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep butorphanol nasal spray out of the reach of children. Keep track of how much nasal spray is left so you will know if any medication is missing.

Taking certain other medications with butorphanol nasal spray may increase the risk of serious or life-threatening breathing problems. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medication and will monitor you carefully. If you use butorphanol nasal spray with other medications and develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with butorphanol nasal spray also increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol or use street drugs during your treatment.

Tell your doctor if you are pregnant or plan to become pregnant. If you use butorphanol nasal spray regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with butorphanol nasal spray and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Butorphanol nasal spray is used to relieve severe pain in people who are expected to need an opioid pain medication and who cannot be controlled by the use of alternative pain medications. Butorphanol is in a class of medications called opioid agonist-antagonists. It works by changing the way the body senses pain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Butorphanol nasal spray comes as a solution (liquid) to spray in the nose. It is usually used as needed for pain but not more often than once every 3 to 4 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Butorphanol nasal spray should relieve your pain soon after you use it. If you are using a low starting dose of butorphanol nasal spray, your doctor may tell you that you may use a second dose if you still have pain 60 to 90 minutes after your first dose. Do not use this second dose unless your doctor tells you that you may. Tell your doctor if you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with butorphanol nasal spray. Do not use more of it or use it more often than prescribed by your doctor. You may receive a dangerous overdose if you use more medication or use your medication more often than prescribed by your doctor.

Do not stop using butorphanol nasal spray without talking to your doctor. If you suddenly stop using butorphanol nasal spray, you may experience withdrawal symptoms such as nervousness, agitation, shakiness, diarrhea, chills, sweats, difficulty falling asleep or staying asleep, loss of coordination,confusion, or hallucinations (seeing things or hearing voices that do not exist). Your doctor will probably decrease your dose gradually.

Before you use butorphanol nasal spray for the first time, read the written directions provided by the manufacturer. Ask your doctor or pharmacist if you have any questions about how to use butorphanol nasal spray.

To use butorphanol nasal spray, follow these directions:

1. Gently blow your nose.
2. Remove the clear cover and protective clip from the bottle.
3. If you are using a new pump or a pump that has not been used in 48 hours or longer, you must prime the pump before use. Hold the bottle so that the nozzle is between your first and second fingers and your thumb is on the bottom. Be sure that the bottle is aimed away from you, other people, and animals. Pump the bottle firmly and quickly (up to 8 strokes) until a fine spray appears.
4. Insert the tip of the sprayer approximately 1/2 inch (1 cm) into one nostril, pointing the tip toward the back of your nose.
5. Close your other nostril with your finger and tilt your head slightly forward.
6. Pump the spray firmly and quickly one time and sniff gently with your mouth closed.
7. Remove the sprayer from your nose. Tilt your head backward and sniff gently for a few seconds.
8. Replace the protective clip and cover on the spray bottle. Put the bottle back in the child-resistant storage container.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with butorphanol nasal spray and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before using butorphanol nasal spray,

• tell your doctor and pharmacist if you are allergic to butorphanol, any other medications, or benzethonium chloride (a preservative found in some medications and personal care products). Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate).

• The following nonprescription or herbal products may interact with butorphanol nasal spray: St. John's wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using butorphanol nasal spray. Do not start these medications while butorphanol nasal spray without discussing it with your healthcare provider.

• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section, a blockage or narrowing of your stomach or intestine, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use butorphanol nasal spray.

• tell your doctor if you have or have ever had problems urinating; a heart attack or other heart problems; seizures; high blood pressure; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions); diabetes; or pancreas, gallbladder, thyroid, kidney, or liver disease.

• tell your doctor if you are breastfeeding. Butorphanol nasal spray can cause shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness in breastfed infants.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using butorphanol nasal spray.

• you should know that butorphanol nasal spray may cause drowsiness, dizziness, or fainting, especially during the first hour after you use the medication. Be sure that you have a comfortable place available in case you need to lie down after you use the medication. Do not drive a car or operate machinery for at least 1 hour after using butorphanol nasal spray. After 1 hour has passed, do not drive until you are sure that you are not dizzy, drowsy, or less alert than usual.

• you should know that butorphanol nasal spray may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using butorphanol nasal spray.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Butorphanol nasal spray is usually used as needed. If your doctor has told you to use butorphanol nasal spray regularly, use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Butorphanol nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• dizziness
• headache
• excessive tiredness
• difficulty falling asleep or staying asleep
• unusual dreams
• constipation
• stomach pain
• nervousness
• abnormally happy or abnormally sad mood
• blurred vision
• ringing in the ears
• ear pain
• unpleasant taste
• dry mouth
• nosebleed
• stuffy or irritated nose
• sore throat

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• slowed or irregular breathing
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• inability to get or keep an erection
• irregular menstruation
• decreased sexual desire
• fainting
• irregular or pounding heartbeat
• lightheadedness
• difficulty urinating
• rash; hives; hoarseness; difficulty breathing or swallowing; or swelling of the face, mouth, tongue or throat

Butorphanol nasal spray may cause other side effects. Call your doctor if you have any unusual problems while you are using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Store butorphanol nasal spray in its child-resistant container, tightly closed and out of reach of children, and in a location that is not easily accessible by others, including visitors to the home. Store it at room temperature and away from excess heat and moisture (not in the bathroom). You must immediately dispose of butorphanol nasal spray as soon as it becomes outdated or is no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, unscrew the cap, rinse the bottle, and place the parts in the waste container. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

While using butorphanol nasal spray, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. Ask your doctor about other ways that you can obtain naloxone (directly from a pharmacy or as part of a community based program). You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Symptoms of overdose may include the following:

• slow or shallow breathing
• difficulty breathing
• excessive sleepiness
• unable to respond or wake up
• limp or weak muscles
• narrowing or widening of the pupils (dark circle in the eye)
• cold, clammy skin
• slowed heartbeat
• unusual snoring

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and laboratory. Your doctor will order certain lab tests to check your body's response to butorphanol.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using butorphanol.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.